Clearance Summary
BIOSTRIP STERILE WOUND CLOSURE STRIP received FDA 510(k) clearance under submission number K946321, sponsored by Cornelia Damsky, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1995-01-12.
- Submission: K946321
- Applicant / Sponsor: Cornelia Damsky, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1995-01-12
Classification & Regulation
This clearance is catalogued under FDA product code FPX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.